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Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboxyamidotriazole
placebo
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed renal cell carcinoma Metastatic or unresectable disease Documented disease progression, even after nephrectomy At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan The following lesions are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions Performance status - CTC 0-2 WBC at least 2,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Creatinine no greater than 2.0 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No baseline neuropathy or cerebellar dysfunction greater than grade 1 At least 4 weeks since prior immunotherapy No prior carboxyamidotriazole No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Concurrent epoetin alfa allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes) At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy See Disease Characteristics At least 4 weeks since prior surgery

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (carboxyaminoimidazole)

Arm II (carboxyamidotriazole, placebo)

Arm Description

Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive oral CAI as above.

Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive a placebo.

Outcomes

Primary Outcome Measures

Proportion of patients progressing on placebo to the proportion progressing on CAI
Proportions of patients with stable disease
Objective response

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006486
Brief Title
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
Official Title
A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor
Detailed Description
OBJECTIVES: I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma. II. Determine the objective response rate in patients treated with this drug. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more). Patients receive oral carboxyamidotriazole (CAI) daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients with stable disease are randomized to one of two treatment arms. Arm I: Patients receive oral CAI as above. Arm II: Patients receive a placebo. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression are unblinded and those on placebo begin oral CAI as above. Patients are followed every 6 months. PROJECTED ACCRUAL: A maximum of 335 patients will be accrued for this study within 15-25 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (carboxyaminoimidazole)
Arm Type
Experimental
Arm Description
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive oral CAI as above.
Arm Title
Arm II (carboxyamidotriazole, placebo)
Arm Type
Experimental
Arm Description
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive a placebo.
Intervention Type
Drug
Intervention Name(s)
carboxyamidotriazole
Other Intervention Name(s)
CAI, carboxyamido-triazole, carboxyaminoimidazole
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Proportion of patients progressing on placebo to the proportion progressing on CAI
Time Frame
Up to 16 weeks
Title
Proportions of patients with stable disease
Time Frame
Up to 16 weeks
Title
Objective response
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed renal cell carcinoma Metastatic or unresectable disease Documented disease progression, even after nephrectomy At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan The following lesions are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions Performance status - CTC 0-2 WBC at least 2,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Creatinine no greater than 2.0 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No baseline neuropathy or cerebellar dysfunction greater than grade 1 At least 4 weeks since prior immunotherapy No prior carboxyamidotriazole No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Concurrent epoetin alfa allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes) At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy See Disease Characteristics At least 4 weeks since prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Stadler
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

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Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

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